Category Archives: Gene therapy

Is Gender a Drug Safety Issue in the Era of Personalized Medicine?

By Lisa Henderson, Applied Clinical Trials. In January 2013, FDA told manufacturers to lower the dose of zolpidem, the insomnia treatment, for women, and suggested a 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). That was based on evidence […]
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Celgene’s Abraxane to Lead Boom in Pancreatic Cancer Market

The global pancreatic cancer treatment market value in the six major countries (U.S., France, Germany, Italy, Spain and the UK) will increase  from $529 million in 2012 to $1.63 billion by 2017, at a Compound Annual Growth Rate (CAGR) of 25.2%, says a new report from GlobalData (London, UK). According to the report, the U.S. will […]
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Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by the Food and Drug Administration with labeling that links prescribing to specific biomarker measures, health plan operators, […]
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European Physicians Have "Insufficient Knowledge of Biosimilars"

European physicians have insufficient knowledge of biosimilars, according to a survey carried out by the Alliance for Safe Biologic Medicines (ASBM). Only 22% of physicians consider themselves “very familiar” with this  category of medicines, and while a majority (54%) have a “basic understanding” of biosimilars, 24% of participants could not define or have not heard about […]
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AbbVie, Amgen, and Roche Most Exposed to Biosimilar Competition

While biosimilar products have been launched in Asia and Europe, they are at least three years away in the US, according to a new report on the global biosimilar drugs market.
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